It seems that Merck has been caught with its hand in the cookie jar. The New England Journal of Medicine (NEJM), that bastion of medical journalism and former bully pulpit of Marcia Angell — author of “The Truth About the Drug Companies“, which tore a new one for the industry — has issued a highly unusual “Expression of Concern,” according to an article in today’s Wall Street Journal (“Medical Journal Says Merck Study Omitted Key Data“).
The data — about three Vioxx patients who suffered heart attacks — were “excised” from the crucial and mull-maligned Vigor clinical trial. According to WSJ: “The medical journal said it had discovered from a computer diskette submitted along with the article that some data were deleted from the manuscript just two days before it was initially submitted for publication in May 2000.”
The NEJM editorial states:
Until the end of November 2005, we believed that these were late events that were not known to the authors in time to be included in the article published in the Journal on November 23, 2000. It now appears, however, from a memorandum dated July 5, 2000, that was obtained by subpoena in the Vioxx litigation and made available to the Journal, that at least two of the authors knew about the three additional myocardial infarctions at least two weeks before the authors submitted the first of two revisions and 41∕2 months before publication of the article. Given this memorandum, it appears that there was ample time to include the data on these three additional infarctions in the article. (See “Expression of Concern“.)
The additional events referred to in the editorial were events that were reported after the pre-specified cut-off date and therefore were not included in the primary analysis reported in the New England Journal article. Nevertheless, these additional events were disclosed to the FDA in 2000, presented publicly at the FDA’s Advisory Committee in February 2001, and included in numerous press releases subsequently issued by Merck. (See “Merck’s Statement on NEJM Editorial“.)
Yes, we’ve seen how Merck trained its sales reps to inform doctors about the Vigor trial. The training program was called “Dodge Ball” as I recall. Whenever a doc raised issues regarding Vigor, the reps were trained to dodge the question with facts from a Merck playlist.
Reporting side effects and adverse events to the FDA is like me confessing to a priest — the data go in but they don’t get out. You’ll note that recently the FDA has quietly dropped its plan to do a Drug Watch Web site so that these “emerging” side effect issues would be made more widely available to docs and patients who may not have read Merck’s press releases (see “FDA Drug Watch: Too Hot to Handle“).
One additional small point was made in the article: “Using word-processing software to track down when changes had been made and by whom, the editors found out the data had been taken out two days before the article was submitted to the journal… [the editors] determined the deletions were made by someone working from a Merck computer.”
WORKING FROM A MERCK COMPUTER!!!
This is evidence of the hand in the cookie jar! Can you imagine the scenario? Do I have to spell it out for you?
Advice to Merck
So your excuse is you had a press release and told the FDA. That’s supposed to let you off the hook? Whatever happened to “Patients Come First”? Is that campaign just a lot of bullshit like I said it was (see “Patients Come First?“).
I also like (meaning I don’t like) your argument that the events “were reported after the pre-specified cut-off date” for the trail. I can tell you that this argument won’t work in front of a jury. It just sounds like you were cooking the books — it’s an accounting trick and people don’t like accountants, especially after Enron. You don’t want that word brought up in trial, do you?
Take a lesson from Japan. According to a BusinessWeek Online article (“Big Pharma Seeks an Image Cure“):
“U.S. drugmakers are scrambling to resuscitate their collective reputation — and they’ve got a lot of room for improvement. Just look at Japan. There, more than 70% of the public believes its pharma industry is trustworthy.
It’s not hard to see why there’s a perception gap, says Hatsuo Aoki, chairman of Tokyo-based Astellas Pharma. Patients in Japan don’t have to deal with sky-high drug prices because the costs are covered by universal health care. What’s more, Japanese drug companies don’t produce the high profits that their U.S. counterparts are known for, and their top executives aren’t similarly compensated.
“The idea of the corporation in Japan is different than in the West,” Aoki says. “We don’t only serve investors. The public and our employees are considered just as important.”
Merck, reaffirm your commitment to patients over profits (CEO George W. Merck once said: “We try never to forget that medicine is for the people. Not for the profits. The profits follow, and if we have remembered that, they have never failed to appear.”) But, I am not talking about more PR and TV commercials!
I suggest Merck initiate a public cleansing like Japanese corporations sometimes have to do. Merck, why don’t you just say you are sorry, you strayed from your core mission, you will pay reasonable damages and you will move on with a new management team that is actually committed to the “Patients Come First” tag line.
A quick death (and, hopefully, a triumphant rebirth) is better than this long, drawn out slow death, one dollar in per share value at a time! This will not only help your investors but will also help you maintain employee morale. Speaking of employee morale, I was quoted in the above-mentioned BusinessWeek article on this very subject: “[pharma companies] need employees who are highly motivated, and morale is pretty bad in the industry right now.”